CTIS2023-504923-20-00招募中1 期
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002) - V940-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,038
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Has surgically resected and histologically confirmed diagnosis of pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous non–small cell lung cancer (NSCLC) as per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines., Has no evidence of disease before randomization., Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy., No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab., Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization., Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening, Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
排除标准
- •Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma., Known additional malignancy that is progressing or has required active treatment within the past 5 years., Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Active infection requiring systemic therapy., HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Received prior neoadjuvant therapy for their current NSCLC diagnosis., Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis., Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor., Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization., Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed., Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration., Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
研究者
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